Regulatory & Clinical Strategy- How to Navigate the FDA
Allison Komiyama, PhD, RAC

Allison is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. She started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. While working at FDA as a biologist and reviewer in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510(k) Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs in support of FDA recognized ISO and ASTM standards. After her time at FDA, she worked as a project manager and regulatory affairs manager at an in vitro diagnostic device company, as well as a senior regulatory specialist and director of regulatory affairs at two boutique consulting firms.

Start Time
6:00 pm
End Time
7:30 pm
TMC|x
2450 Holcombe Blvd Suite X, Houston, TX 77021

Event Description

Sure, your invention is amazing, and your business plan is solid, but before your product ever reaches a patient, you need to get regulatory approval. We'll introduce you to Allison Komiyama, a former FDA reviewer and discuss what it's like dealing with the FDA today (hint: it's not as bad as you think). We'll also cover strategies for getting approval outside the US and how your path might be different depending on whether you're in Health IT, Med Devices, Biotech, or Pharma.

  • ‍Regulatory Timeline
  • Navigating FDA Guidance
  • Drugs vs Devices vs Heath IT
  • Case Studies